Laboratorios Dr. Collado, S.A.
Form 483 issued April 21, 2023 · Santo Domingo, Dominican Republic
- Inspection
- Apr 17 – Apr 21, 2023
- Investigators
- Clinton J. Lott· Susanna E. Ford
- Observations
- 6
- Pages
- 5
- FEI number
- 3000989764
In short: On April 21, 2023, FDA issued a Form 483 with 6 observations to Laboratorios Dr. Collado, S.A. in Santo Domingo, Dominican Republic (FEI 3000989764) after an inspection that ran Apr 17 – Apr 21, 2023. The investigators were Clinton J. Lott and Susanna E. Ford. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 02
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through…
- 03
Deviations from written production and process…
- 04
Written records are not always made of…
This inspection in context
Clinton J. Lott
10 documents · 2021–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLaboratorios Dr. Collado, S.A. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Laboratorios Dr. Collado, S.A.?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Laboratorios Dr. Collado, S.A.?
Clinton J. Lott and Susanna E. Ford are named on this Form 483, for the inspection of Apr 17 – Apr 21, 2023. Each investigator has a profile showing what they cite most.
When was Laboratorios Dr. Collado, S.A. inspected by FDA?
The inspection ran Apr 17 – Apr 21, 2023, and the Form 483 is dated April 21, 2023.
How do I get the full Form 483 for Laboratorios Dr. Collado, S.A.?
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.