Staar Surgical (NSDQ:STAA) offered updates on the FDA warning it received in February as it released its quarterly earnings late last month.
The company received a warning in February about its plant in Monrovia, Calif., where the company is headquartered.
The FDA inspected the Monrovia facility from Nov. 14 last year through Feb. 4, finding 10 problems with the way Staar documents product changes and other issues, the company said.
Staar executives updated on the situation, saying they had held products for further testing to meet quality standards and rejected and scrapped any products where deposits had been detected.
“The remainder of the product from these production runs all passed final inspection and the root cause of the deposits was identified. To make a cautious product quality decision, we voluntarily put that product on hold and took advantage of the FDA being onsite during their inspections and presented test protocols to verify that the product meets our standards for quality. We are testing these lenses pursuant to the protocol submitted to the FDA and we will present the FDA with our results when testing is complete and in the meantime we anticipate that will be able to fill demand from current inventory that is not on hold and also current production,” CFO Steve Brown said during an earnings call.
Staar reported earnings that missed expectations but revenues that surpassed them, despite shrinking from the same quarter last year.
The company reported losses of $1.6 million, or 4¢ per share, on sales of $18.7 million for the 30 days ended July 3. That amounts to a 10.6% reduction in losses, with sales shrinking 6.9% compared to the same period last year.
Analysts on Wall Street were looking for losses per share of 2¢, which Staar missed by an equal 2¢, and revenue of $17.9 million, which Staar squeaked past.
Shares stayed steady on the day of release, moving less than 1%, but have fallen 12% between July 30 and August 13.
“During the quarter, we continued our positive momentum in strengthening manufacturing efficiency and output. Our yields continue to improve and our TICL quarterly shipments were the highest ever recorded during the second quarter. Importantly, we continue our steadfast commitment and focus on meeting all FDA remediation requirements and the building of an enhanced quality system,” CEO Caren Mason said in a press release.
