FDA 483 - Unknown Company - March 10, 2011

On March 10, 2011, an FDA inspection was conducted at Alvin Weaver, a shell egg producer located at 52 Burkholder Lane, Frederickburg, PA 17026. The inspection revealed three observations regarding record-keeping deficiencies.

Observation 1 noted that required records did not include the time of the activity they reflected. Specifically, the records lacked timestamps for operations.

Observation 2 indicated that all required records did not have the signature or initials of the person performing the operation or creating the record. The records were missing signatures of the individuals performing the operations.

Observation 3 stated that all required records did not include the name and location of the farm. The firm's name and farm location were absent from the required records.

These observations were made by Investigators LT John M. Mastalski and LCDR Margaret E. Digennaro. The document serves as an inspectional observation report and does not represent a final Agency determination of compliance.