FDA Warning Letters: March 2025 Edition
Indian CDMO denies manufacturing drug, contract testing lab pulled up for deficiencies, and lessons learned from Sanofi’s warning letter.
Stephanie Vine | | 3 min read | Hot Topic
Bart Simpson’s “I didn’t do it” comes to mind
Ignoring multiple FDA requests for records and other information is a surefire way to a Warning Letter – as Zenzi Pharmaceutical Industries in India has discovered. Zenzi is a CDMO of prescription products delivered to the US; however, Zenzi and their customer seem to disagree over their working relationship. After ignoring requests from the FDA for records, the company eventually responded – but they didn’t provide any records. Instead, they denied producing the drug for the US customer. Unfortunately for them, the customer passed a manufacturing contract to the FDA.
“On November 13, 2024, your Vice President of Quality responded via e-mail stating your firm does not supply (b)(4) ((b)(4) Injection USP) labeled with the address of (b)(4) (your customer). This is in contradiction to records provided by your customer,” states the warning letter. “A contract manufacturing agreement provided by the (b)(4) owner and other records show that you are the manufacturer of (b)(4), which was shipped to the United States. These records include your registration file, your certificate of analysis, and a batch production record for (b)(4).”
All drugs and drug products manufactured by the company were placed on an import alert in February 2025.
Contract testing lab suffers cGMP woes
The FDA advises Florida’s ABR Laboratory to hire a consultant to fix its cGMP issues. The company has not been using suitable methods to test clients’ OTC drugs and failed to investigate out-of-range deviations in temperature and humidity readings in its lab equipment.
The letter states, “For example, your 2–8 °C refrigerator was out of range for more than 24 hours reaching temperatures of up to 17.4°C. This refrigerator houses the reference microorganisms used in your growth promotion tests. This deviation was not identified or investigated. Storing of reference microorganisms outside of their acceptable range compromises their ability to grow, thereby undermining their value as reference organisms and the accuracy of the results.”
Footprints in the lab
During an FDA inspection, operators at Tyche Industries in India admitted to falsifying temperature data for a drying oven that wasn’t switched on during manufacturing. A backdated calculation sheet was also given to the FDA investigator.
Raw material testing issues were also noted, as well as insufficient equipment cleaning. For example: “FDA documented rust-like residues inside (b)(4) non-dedicated (b)(4) used in the production of (b)(4). In addition, FDA documented bare footprints inside another (b)(4) used in the production of (b)(4). Each (b)(4) was labeled that it had been cleaned and was ready for use.”
Microorganisms detected in water
Strukmyer LLC dba Strukmyer Medical, based in Texas, isolated microorganisms, such as Burkholderia, Pseudomonas, Staphylococcus, Bacillus, and Aspergillus species, from the water system used to manufacture OTC products intended to treat wounds and burns. The warning letter states that the company did not adequately investigate the root cause or implement corrective actions.
The letter also cites issues with cleaning. “You failed to demonstrate your cleaning and disinfection practices are adequate to remove all contaminants from the equipment used to manufacture your topical OTC drug products. For example, your cleaning validation only tested for the absence of Gram-negative bacteria, but you have previously isolated fungi and gram-positive microorganisms from your water system.”
The company also has not been testing incoming components, including glycerin, for purity, strength and conformity. Glycerin is at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination.
Shame for Sanofi
It’s unusual to see a warning letter for a big pharma player. Sanofi received a letter for failing to investigate deviations involving bioreactor runs. “FDA documented that approximately 20 percent of bioreactor runs attempted between January 2022 and July 2024 were rejected for contamination or other quality failures. This rate is excessive and calls into question the state of control of your process. You failed to conduct adequate investigations into critical deviations, including multiple microbiological contamination events recorded in this timeframe.”
The company also “repeatedly” deviated from validated manufacturing processes and was pulled up over equipment suitability. For example: “Mobile carts used in the setup of (b)(4) units required operators to get down to the floor and manually lock and unlock the cart brakes despite previously determining equipment proximity to the floor as a contributing root cause in microbiological contamination events.”
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