Symed Labs Limited
Form 483 issued December 6, 2024 · Sangareddy, India
- Investigator
- Bijoy Panicker
- Observations
- 2
- Pages
- 2
- FEI number
- 3007164063
In short: On December 6, 2024, FDA issued a Form 483 with 2 observations to Symed Labs Limited in Sangareddy, Telangana (FEI 3007164063). The investigator was Bijoy Panicker. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmSymed Labs Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Symed Labs Limited?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Symed Labs Limited?
Bijoy Panicker is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Symed Labs Limited inspected by FDA?
This Form 483 is dated December 6, 2024.
How do I get the full Form 483 for Symed Labs 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.