COOPERSURGICAL INC
Overview
COOPERSURGICAL INC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering COPPER T MODEL TCU 380A INTRAUTERINE CONTRACEPTIVE.
Core services & business areas
API / Drug Master Files
COOPERSURGICAL INC holds 1 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- COPPER T MODEL TCU 380A INTRAUTERINE CONTRACEPTIVEActive1989-11-17
FDA compliance signals
13 FDA enforcement records linked to this company.
- 4832024-05-21
Storage under appropriate conditions
- 4832022-03-04
Investigations of discrepancies, failures
- 4832022-03-04
Written procedures fail to include
- 4832022-03-04
Scientifically sound laboratory controls
- 4832022-03-04
Written record of investigation incomplete
- 4832022-03-04
Written record of complaint to include findings, follow-up
- recall — Class I2022-02-23
Non-sterility
- warning_letter2021-02-12
FDA Warning Letter (drug product)
- 4832019-08-01
Written procedures not established/followed
- 4832019-08-01
Complaint Handling Procedure
- 4832017-03-28
Procedures not in writing, fully followed
- 4832014-03-21
Test method modification records do not include
- 4832014-03-10
Complaint Investigation/Follow-Up Findings
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