FDA WARNING_LETTER - The Tender Corporation - November 25, 2019

On July 23, 2020, the FDA issued a Warning Letter to Tender Corporation following an inspection from November 12-25, 2019, at their Littleton, New Hampshire drug manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm failed to ensure laboratory records contained complete data, with instances of unofficial injections on HPLC systems not included in batch disposition records. Data integrity issues were noted, such as shared login credentials for the Infrared Spectrophotometer (IR) system, allowing unauthorized data manipulation. The firm's retrospective review was deemed inadequate, limited in scope, and unable to retrieve metadata from previous software. 2. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** The firm lacked scientifically sound procedures for testing active ingredients (e.g., sodium bicarbonate) in "After Bite" products. Test methods exhibited issues like abnormal peaks and system suitability failures without comprehensive investigations or timely corrective and preventive actions (CAPA). 3. **Inadequate Complaint Handling (21 CFR 2