FDA 483 - Time-Cap Laboratories, Inc. - May 05, 1998

The FDA Form 483 details numerous deficiencies at a pharmaceutical manufacturing facility.

**Facility and Operations:** The firm manufactures ANDA products, including Nitroglycerin ER Capsules, Comhit LA, Bisacodyl E/C Tablets, Aspirin E/C Tablets, Cold Capsules, and Phenylephrine HCl stock pellets. Operations involve pellet blending, coating, encapsulation, and tableting.

**Violations and Observations:** * **Unapproved Ingredients:** Nitroglycerin 2.5 mg ER Capsules (lots P056H, J062H) used anti-static powder not in the ANDA. An anti-static powder batch (C009H) was produced without inventory usage records. * **Process Control & Specificity:** * No acceptance range for timing solution in Nitroglycerin stock pellets; quantities varied significantly (e.g., L053H, B074H, K037H). * Master batch records for Nitroglycerin ER Capsules (2.5 mg, 6.5 mg, 9.0 mg) lacked specificity for seal coating, neutral pellet coating (how performed, quantities), and active ingredient application (spray rate, placement, apparatus). * Batch manufacturing instructions for active coated stock pellets (e.g., Phenylephrine HCl, lots M087H, G051H) were poorly defined,