Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
Form 483 issued July 12, 2021 · Manati, Puerto Rico
- Inspection
- May 11 – Jul 12, 2021
- Investigator
- Adaliz Santaliz-Cruz
- Observations
- 9
- Pages
- 18
- FEI number
- 2650089
In short: On July 12, 2021, FDA issued a Form 483 with 9 observations to Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company in Manati, Puerto Rico (FEI 2650089) after an inspection that ran May 11 – Jul 12, 2021. The investigator was Adaliz Santaliz-Cruz. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
This inspection in context
Adaliz Santaliz-Cruz
6 documents · 2012–2022
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBristol-Myers Squibb Holdings Pharma Ltd. Liability Company history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?
Adaliz Santaliz-Cruz is named on this Form 483, for the inspection of May 11 – Jul 12, 2021. Each investigator has a profile showing what they cite most.
When was Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company inspected by FDA?
The inspection ran May 11 – Jul 12, 2021, and the Form 483 is dated July 12, 2021.
How do I get the full Form 483 for Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?
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.