Unichem Laboratories Limited
Form 483 issued July 31, 2019 · Pilerne, India
- Investigator
- Adetutu Gidado
- Observations
- 4
- Pages
- 2
- FEI number
- 3005497507
In short: On July 31, 2019, FDA issued a Form 483 with 4 observations to Unichem Laboratories Limited in Pilerne, Goa (FEI 3005497507). The investigator was Adetutu Gidado. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 3 of 4 observations.
Most cited: 21 CFR 211.68 (2×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Backup data is not assured as exact and complete through keeping hard…
- 03
Written procedures for sanitation…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmUnichem Laboratories Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unichem Laboratories Limited?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Unichem Laboratories Limited?
Adetutu Gidado is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Unichem Laboratories Limited inspected by FDA?
This Form 483 is dated July 31, 2019.
How do I get the full Form 483 for Unichem Laboratories Limited?
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.