FDA 483 - New England Compounding Pharmacy, Inc. - April 16, 2002

On April 9, 10, and 16, 2002, the FDA inspected New England Compounding Pharmacy, Inc. at 697 Waverly Street, issuing a Form 483 to Barry Cadden, R. Ph, Owner and Director of Pharmacy.

Observations included: 1. For Betamethasone Repository Injection (Betamethasone Acetate and Betamethasone Sodium Phosphate Suspension 6 mg/ml), a sterile product, bulk compounded product is sampled for sterility and endotoxin testing immediately after sterilization in a beaker. Individual vials are not filled until test results are received, which can take up to a week. During this period, the beaker and its contents are stored in a laminar flow hood, covered only by multiple layers of aluminum foil. 2. Samples taken immediately after autoclave sterilization are not representative of the product remaining in the original beaker for up to one week post-sampling. 3. The firm's autoclave cycle validation does not account for the autoclaved bulk product not being transfilled into final containers (vials) for up to one week. 4. Lot number 02012002@027 was generated in the computerized record-keeping system, but no associated records could be retrieved, making it impossible to determine if the lot was distributed without records or if its preparation was canceled without proper documentation.