28/05/2026
FDA WARNING LETTER SUMMARY
Alchymars ICM SM Private Limited
A-14 & 20 Sidco Pharmaceutical Complex
Alathur 603110 Tamil Nadu
India
"1. Failure to ensure that equipment is maintained.
Your firm failed to adequately maintain the (b)(4) used to manufacture (b)(4) API for the U.S. market. Our investigator documented (b)(4) in the (b)(4) manufacturing workshop in various levels of disrepair, including cracked, taped, and deteriorating (b)(4) gaskets, rust-like residues on product-contact surfaces such as (b)(4), and cracked (b)(4) inside one of the (b)(4). These findings directly contradict your firm’s own cleaning and preventive maintenance records, which had documented the condition of all these (b)(4) as “ok.” Additionally, our investigator observed wet paint on one of your (b)(4) while production activities were ongoing.
In your response, you acknowledge the deteriorated condition of your equipment and attributed the deficiencies to inadequacies in your cleaning program and absence of a lifecycle management program for your equipment. You also acknowledge that your inaccurate recordkeeping stemmed from “insufficient inspection rigor.” As corrective action, you have initiated physical repair of all equipment and a complete overhaul of procedures for cleaning, maintenance, inspection, and gasket management.
Your response is inadequate because your investigation does not extend to testing residues found in your equipment or retain samples to assess the potential impact on product quality. Furthermore, your response fails to explain the inability of your quality system, despite having numerous checklists and procedures already in place, to identify and proactively address these obvious equipment maintenance issues.
It is your responsibility to ensure your equipment maintenance program is comprehensive and includes appropriate assessment of equipment failures and their impact to product quality.
In response to this letter, provide:
Your plan to ensure that personnel responsible for maintaining equipment are appropriately trained and capable of performing their assigned duties.
Your corrective action and preventive action (CAPA) plan to comprehensively address any gaps identified from the assessment of your equipment maintenance program including, but not limited to, inadequate quality unit oversight, inadequate trending of preventive maintenance, and lack of detailed procedures.
Provide an independent review that determines the effectiveness of your CAPA including, but not limited to:
o Enhancements to cleaning and maintenance procedures including determination of specific frequencies and locations to be cleaned for all relevant equipment.
o Adequacy of equipment maintenance and repair history for all (b)(4).
2. Failure to properly maintain buildings and facilities used in the manufacture of API.
You failed to maintain your drug manufacturing facility in a good state of repair. Specifically, our investigator observed the following deficiencies in the (b)(4) production building during the inspection:
Water condensation from (b)(4)-216 on the (b)(4) floor was actively falling onto the catwalk and subsequently dripping onto the working space for (b)(4)-207, resulting in standing water around that (b)(4).
Water from the bottom of (b)(4)-203, (b)(4)-204, and (b)(4)-209 on the (b)(4) floor was dripping onto the production floor and the outer surfaces of (b)(4)-204.
You placed (b)(4) drums below the water drips and (b)(4) sheeting on the catwalk to shield the (b)(4) from overhead dripping water".
