OTC / drug CGMP
OTC drug CGMP warning-letter patterns worth tracking.
Recent public warning letters show a useful reader pattern: the company name matters less than the issue FDA had to repeat.
For OTC drug letters, the repeated themes often land in manufacturing controls, lab controls, process validation, and quality-unit oversight.
That does not make every letter the same. It gives readers a way to scan the public record without opening each source page cold.
What to tag
CGMPprocess validationlaboratory controlsquality unit
How to read the source
Start with the issue date, product lane, cited systems, and whether FDA points to repeat deficiencies. Then open the source record before treating the summary as useful.