1Other quality system
The firm routinely stores compounded drug products in a REDACTED (b)(4) pending deliv ery to patients.
Inspection Record
D.R. Pharmacy Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
(b)(4 ) The plastic pouches REDACTED (b)(4) ) used to package the final compounded, REDACTED (b)(4).On 3/14/06, one bag of REDACTED (b)(4) currently in use was observed to be open and unsealed in the firm's drug container storage area which also operates as an employee lunchroom.
3Other quality system
After 2/03, the firm did not conduct testing for potency of any compounded drug products.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
