Warner Graham LLLP
Form 483 issued May 21, 2024 · Cockeysville, Maryland
- Inspection
- May 13 – May 21, 2024
- Investigator
- David A. Oluwo
- Observations
- 6
- Pages
- 6
- FEI number
- 1110202
In short: On May 21, 2024, FDA issued a Form 483 with 6 observations to Warner Graham LLLP in Cockeysville, Maryland (FEI 1110202) after an inspection that ran May 13 – May 21, 2024. The investigator was David A. Oluwo. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 04
Procediues designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmWarner Graham LLLP history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Warner Graham LLLP?
FDA listed 6 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Warner Graham LLLP?
David A. Oluwo is named on this Form 483, for the inspection of May 13 – May 21, 2024. Each investigator has a profile showing what they cite most.
When was Warner Graham LLLP inspected by FDA?
The inspection ran May 13 – May 21, 2024, and the Form 483 is dated May 21, 2024.
How do I get the full Form 483 for Warner Graham LLLP?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.